510(k) Report

510(k) · Cleared

Cleared

Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,

K110452510(k) SpecialCleared Apr 20, 201163-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unilens Corp., USA · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 20, 2011 as substantially equivalent to K940777 (Unilens Corp., USA, 1994) and 17 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1981.

Decided
Apr 20, 2011
Review
63 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
18

Its longest line of descent runs back 7 generations to P810005 (1981). 36 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2005: 2 other ancestors2004: 1 other ancestor2000: 2 other ancestors1997: 3 other ancestors1996: 2 other ancestors1994: 4 other ancestors2007: 1 other ancestor1999: 2 other ancestors1985: 1 other ancestor2003: 1 other ancestor1984: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestorP810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997K020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalled×2: 2 generations cleared close together, K100221 (2010), K100456 (2010) 1980198519901995200020052010
Other ancestors, by generation 1 generation back: 13 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 1 other ancestor K100456 · Cvue Advanced Definitive · Unilens Corp., USA · 2010K100221 · INTELLIWAVE3 · Art Optical Contact Lens, Inc. · 2010K052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalledK033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981−50
  1. Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
  2. 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
  3. 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
  4. 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
  5. 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
  6. 2 generations backK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
  7. 1 generation backK100456 Cvue Advanced DefinitiveUnilens Corp., USA · 2010
  8. This deviceK110452 Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue…Unilens Corp., USA · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7P810005Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care1981—
−6K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation1997—
−5K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation2002—
−4K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal…Ciba Vision Corporation20041
−3K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.20051
−2K100221INTELLIWAVE3Art Optical Contact Lens, Inc.2010—
−1K100456Cvue Advanced DefinitiveUnilens Corp., USA2010—
0 (this device)K110452Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto…Unilens Corp., USA2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199440
199510
199620
199730
199920
200020
200110
200210
200310
200410
200520
200710
200820
FIG. 1 — Lineage of K110452, 1981–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPL device

  1. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (18)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*P820005(Polymacon) Contact Lenses
FDA lists this PMA only through its supplements; the earliest we hold is P820005/S001 (Jul 21, 1982).
Summary page 1
…KI 10452 - Bundled Special 510 (k) for Parametric Release from Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K97…
Salvatori Ophthalmics Mfg. Corp.—
*P850002Alges (TM) (Hefilcon a) Contact Lens
FDA lists this PMA only through its supplements; the earliest we hold is P850002/S001 (Feb 28, 1986).
Summary page 1
…- Bundled Special 510 (k) for Parametric Release from Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K00…
Unilens Corp., USA—
*P880101Aquaflex[Tetrafilcon a] Contact Lenses/Shelf Life
FDA lists this PMA only through its supplements; the earliest we hold is P880101/S003 (Mar 5, 1990).
Summary page 1
…) for Parametric Release from Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K…
Unilens Corporation, USA—
*P880102Lombart (Polymacon) Soft Contact Lenses
FDA lists this PMA only through its supplements; the earliest we hold is P880102/S001 (Mar 5, 1992).
Summary page 1
…ametric Release from Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743'…
Lombart Lenses, Ltd.—
*K940777Bayvue (Polymacon) Soft (Hydrophilic) Contact Lens
Summary page 1
…elease from Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743'…
Unilens Corp., USA1994—
*K941836Unilens 38 Soft Aspheric Contact Lens
Summary page 1
…om Moist 1-leaf Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K08…
Unilens Corp., USA1994—
*K942372Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens
Summary page 4
…Contact Lens 38 Daily Wear Soft 51() 50) Simulvue LLI2K942372 07/07/94 (hydrophilic) II Ophthalmic LPL…
Unilens Corp., USA1994—
*K942494Lifestyle Multivue-S (Polymacon) Soft Hydrophilic Contact Lens
Summary page 1
…lization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Tr…
Permeable Technologies, Inc.1994—
*K960926Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens
Summary page 1
…for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Devic…
Unilens Corp., USA1996—
*K961428Soft-55 Daily Wear Contact Lens
Summary page 1
…(hydrophilic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic C…
Lombart Lenses, Ltd.1996—
*K965012Lifestyle Break Thru (Polymacon)
Summary page 1
…lic) daily wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Le…
The Lifestyle Co., Inc.1997—
*K971647LL BI-Focal, Daily Wear Contact Lens
Summary page 1
…y wear contact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for…
Lombart Lenses, Ltd.1997—
*K000529Lifestyle MV2 (TM) Toric (Polymacon) Soft (Hydrophilic) Multifocal Contact Lens for…
Summary page 1
…ntact lenses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wea…
The Lifestyle Co., Inc.2000—
*K002408Axion Plus (Methafilcon a) Soft (Hydrophilic) Aspheric Contract Lens
Summary page 1
…ses cleared under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Reg…
Unilens Corp., USA2000—
*K041608C-Vue 55 Toric (Methafilcon a) Multifocal Contact Lens
Summary page 1
…ed under P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation N…
Unilens Corp., USA2004—
*K050743Aquaflex 2 (Tefilcon) Contact Lens
Summary page 1
…P820005, P850002, P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21…
Unilens Corp., USA2005—
*K082393Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens
Summary page 1
…P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulat…
Unilens Corp., USA2008—
*K100456Cvue Advanced Definitive
Summary page 1
…P880101, P880102, K940777. K941836, K942.372, K(942494. K960926, K96 1428, K965012, K971647, K000529, K002408, K041608, K050743' K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name:…
Unilens Corp., USA2010—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 32 ancestors have a recall of any class.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses

Indications for use as stated in the FDA 510(k) statement.

More from Unilens Corp., USA

38 FDA decisions under this applicant name. See the company

  • P890040/S008Soft-Form 55EW; LL-55; Softcon EW2Unilens Corp., USA · 2016
  • K142851CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact LensUnilens Corp., USA · 2014
  • P890040/S007Sof-Form 55 EW, LL-55, Softcon EW 2Unilens Corp., USA · 2013
  • K121652Cvue Advanced Hydra VueUnilens Corp., USA · 2012
  • K100456Cvue Advanced DefinitiveUnilens Corp., USA · 2010

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K110452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110452: Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110452

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026